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Entamoeba Histolytica Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

by Sansure Biotech Inc. 2 variants

Ref S3230E-24

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06955792734388 Basic UDI-DI 06955792734388UDI-DIDate31 Aug 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Entamoeba Histolytica Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Model / Reference
S3230E-24
Primary DI / UDI-DI
06955792734388
Basic UDI-DI
B-06955792734388
EMDN Code
W0105050201 Entamoeba histolytica
Device Class
Class IVD General
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000011392
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No